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FDA 510(k)

PROSTATE SPECIFIC ANTIGEN CONTROL

K-Number: K973099 · 1997-09-29

ApplicantDade Chemistry Systems, Inc.
Decision Date1997-09-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROSTATE SPECIFIC ANTIGEN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K973099. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATE SPECIFIC ANTIGEN CONTROL?

PROSTATE SPECIFIC ANTIGEN CONTROL is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K973099.

When did PROSTATE SPECIFIC ANTIGEN CONTROL receive FDA 510(k) clearance?

PROSTATE SPECIFIC ANTIGEN CONTROL received FDA 510(k) clearance on 1997-09-29, under 510(k) number K973099.

Who is the listed applicant for PROSTATE SPECIFIC ANTIGEN CONTROL?

The FDA 510(k) record lists Dade Chemistry Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSTATE SPECIFIC ANTIGEN CONTROL?

The FDA product code for PROSTATE SPECIFIC ANTIGEN CONTROL is JJX.

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Other records listing Dade Chemistry Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973650TROPONIN (TROP) METHODK973100PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATORK973101PROSTATE SPECIFIC ANTIGEN METHODK971141FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEMK970387HUMAN CHORIONIC GONADOTROPIN METHODK970336MMB CALIBRATOR

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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